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KabiCare Patient Support Program forSTIMUFEND® (pegfilgrastim-fpgk)

Stimufend Box Packaging and Injection Syringe

STIMUFEND® (pegfilgrastim-fpgk) from Fresenius Kabi is a man-made form of granulocyte colony-stimulating factor (G-CSF). STIMUFEND is FDA approved and is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome H-ARS).

Important Safety Information

Program Support Areas

Learn more about the program support for STIMUFEND® (pegfilgrastim-fpgk) offered through KabiCare by selecting an area of support below:

Patient Support Guide

Our Patient Support Guides can assist with the enrollment process and provide appropriate information regarding patient insurance coverage, copay assistance, and other support programs. Our online portal keeps you up to date on the progress for any claim or Prior Authorization (PA) issues.

New Patient Information

A patient brochure will be mailed to your patient once enrollment is complete. Inside the brochure your patient will find ways to access important information about their medication and other resources available to them while on treatment.

Click here to learn more about enrollment

Benefits Investigation

Once a patient is enrolled, KabiCare conducts the benefits investigation on behalf of the patient to confirm insurance coverage details. The information is provided to you, your practice, and your patient to aid in patient access.

Prior Authorizations Support

If a prior authorization is required by insurance, the Patient Support Guide will alert your office of the requirement and confirm the submission method preferred by the payer. The Patient Support Guide will work closely with you and your staff to ensure the appropriate information is shared with the payer.

Claims Appeals Support

Should a claim or prior authorization be denied, a KabiCare Patient Support Guide will assist as you prepare the documentation needed to support an appeal.

Obtaining a determination from the insurance company is sometimes delayed for any number of reasons. Field Reimbursement Managers will be available to help identify and overcome obstacles in an effort to prevent any further delays.

Billing and Coding Support

KabiCare has developed reimbursement resources for STIMUFEND® (pegfilgrastim-fpgk) treatment to help you submit claims and understand eligibility for reimbursement.*

Bridge to Therapy Program Enrollment

The Bridge to Therapy Program provides commercially insured patients access to treatment without delay while they are waiting for insurance approval. Eligibility criteria apply**.

**Eligibility criteria apply. Patients are not eligible for commercial copay assistance or Bridge to Therapy support if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program.

Commercial Copay Support

If your patient has commercial insurance, they may be eligible** for the copay program that lowers their out-of-pocket costs to as little as $0/month for treatment with an annual maximum. Your patient will have a choice to enroll in the full KabiCare Patient Support Program , or just simply enroll in STIMUFEND Copay Support.

Learn more about the copay program or enroll your patient in copay ONLY

Patient Assistance Program

If your patient does not have insurance and/or cannot afford their medication, they may be eligible for additional assistance through the Patient Assistance Program* or through independent nonprofit patient assistance programs. Eligibility criteria apply.‡

*Terms and conditions apply

**Eligibility criteria apply. Patients are not eligible for commercial copay assistance or Bridge to Therapy support if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program.

‡Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Fresenius Kabi has no control over these programs.

Specialty Pharmacy Support

The Patient Support Guide will coordinate with the specialty pharmacy to secure dispensing of the medication as needed.

Transportation and Lodging

KabiCare will investigate potential transportation and lodging benefits that may be offered by your patient’s insurance. A list of independent foundations‡ are provided to patients when treatment-related transportation and lodging assistance are needed.

‡Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Fresenius Kabi has no control over these programs.

What is Febrile Neutropenia?

Cytotoxic chemotherapy suppresses the hematopoietic system, impairing the immune system. Neutropenia is characterized by a reduction in neutrophils below normal counts, usually occurring within 7 to 12 days following cancer chemotherapy.1 Neutropenia is defined as an absolute neutrophil count (ANC) of less than 500 cells per microliter following cytotoxic chemotherapy, or by an ANC expected to decrease to less than 500 cells per microliter within 48 hours. Febrile Neutropenia is neutropenia with a single temperature greater than or equal to 38.3°C (101°F) orally or greater than or equal to 38°C (100.4°F) over an hour.2

What are the risk factors for Febrile Neutropenia?

The risk factors for Febrile Neutropenia include the extent of disease, chemotherapy regimen, and patient risk factors. Patient risk factors include (not a comprehensive list):

  • Prior chemotherapy or radiation
  • Advanced age
  • Renal and hepatic impairment
  • Bone marrow involvement by tumor
  • Recent surgery and/or open wounds3,4

Febrile Neutropenia Resources

Useful downloadable resources for you:

Tips and Helpful resources for your patients:

Please refer to Stimufend website (Opens in a New Window) for additional information about indication, dosing, and treatment.

References

  1. Neutropenia and risk of infection. CDC website. Accessed August 26, 2024. http://www.cdc.gov/cancer/preventinfections/pdf/neutropenia.pdf (PDF Opens in a New Window)
  2. Freifeld AG, Bow EJ, Sepkowitz KA, et al. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. https://doi.org/10.1093/cid/cir073 (Opens in a New Window)
  3. Crawford, J. Risk Assessment and Guidelines for First-Cycle Colony-Stimulating Factor Use in the Management of Chemotherapy-Induced Neutropenia. Oncology. 2006;20(5):Suppl4. PMID:16736985.
  4. Lyman GH, Lyman CH, Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist. 2005;10(6):427-437
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IMPORTANT SAFETY INFORMATION

Indications and Usage
Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Stimufend is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Limitations of Use
Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Contraindication

  • Stimufend (pegfilgrastim-fpgk) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
  • Reactions have included anaphylaxis

Splenic Rupture

  • Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products
  • Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

  • ARDS can occur in patients receiving pegfilgrastim products
  • Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Stimufend
  • Discontinue Stimufend in patients with ARDS

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products
  • The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial anti-allergic treatment
  • Permanently discontinue Stimufend in patients with serious allergic reactions

Use in Patients with Sickle Cell Disorders

  • In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving pegfilgrastim products
  • Discontinue Stimufend if sickle cell crisis occurs

Glomerulonephritis

  • Has occurred in patients receiving pegfilgrastim products
  • Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
  • Generally, events resolved after dose-reduction or discontinuation of pegfilgrastim products
  • If suspected, evaluate for cause and if cause is likely, consider dose-reduction or interruption of Stimufend

Leukocytosis

  • Increased white blood cell counts of 100 x 109/L have been observed
  • Monitoring of complete blood count (CBC) during Stimufend therapy is recommended

Thrombocytopenia

  • Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts

Capillary Leak Syndrome (CLS)

  • CLS has been reported after G-CSF administration, including pegfilgrastim products
  • Characterized by hypotension, hypoalbuminemia, edema and hemoconcentration
  • Episodes vary in frequency, severity and may be life-threatening if treatment is delayed
  • Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

  • G-CSF receptor has been found on tumor cell lines
  • The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

  • MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis

  • Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy
  • Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count)
  • Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Stimufend if aortitis is suspected

Nuclear Imaging

  • Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results

Most common adverse reactions

  • Bone pain
  • Pain in extremity

Please see Stimufend full prescribing information (PDF Opens in a New Window).

Stimufend Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.

IMPORTANT SAFETY INFORMATION

Indications and Usage
Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Stimufend is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Limitations of Use
Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Contraindication

  • Stimufend (pegfilgrastim-fpgk) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
  • Reactions have included anaphylaxis

Splenic Rupture

  • Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products
  • Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

  • ARDS can occur in patients receiving pegfilgrastim products
  • Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Stimufend
  • Discontinue Stimufend in patients with ARDS

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products
  • The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial anti-allergic treatment
  • Permanently discontinue Stimufend in patients with serious allergic reactions

Use in Patients with Sickle Cell Disorders

  • In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving pegfilgrastim products
  • Discontinue Stimufend if sickle cell crisis occurs

Glomerulonephritis

  • Has occurred in patients receiving pegfilgrastim products
  • Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
  • Generally, events resolved after dose-reduction or discontinuation of pegfilgrastim products
  • If suspected, evaluate for cause and if cause is likely, consider dose-reduction or interruption of Stimufend

Leukocytosis

  • Increased white blood cell counts of 100 x 109/L have been observed
  • Monitoring of complete blood count (CBC) during Stimufend therapy is recommended

Thrombocytopenia

  • Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts

Capillary Leak Syndrome (CLS)

  • CLS has been reported after G-CSF administration, including pegfilgrastim products
  • Characterized by hypotension, hypoalbuminemia, edema and hemoconcentration
  • Episodes vary in frequency, severity and may be life-threatening if treatment is delayed
  • Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

  • G-CSF receptor has been found on tumor cell lines
  • The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

  • MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis

  • Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy
  • Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count)
  • Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Stimufend if aortitis is suspected

Nuclear Imaging

  • Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results

Most common adverse reactions

  • Bone pain
  • Pain in extremity

Please see Stimufend full prescribing information (PDF Opens in a New Window).

Stimufend Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.